Gait training using a wearable robotic hip device for incomplete spinal cord injury: A preliminary study.

CONTEXT/OBJECTIVE: To explore changes in gait functions for patients with chronic spinal cord injury (SCI) before and after standard rehabilitation and rehabilitation with a wearable hip device, explore the utility of robot-assisted gait training (RAGT), and evaluate the safety and dose of RAGT. DESIGN: Single-arm, open-label, observational study. SETTING: A rehabilitation hospital. PARTICIPANTS: Twelve patients with SCI. INTERVENTIONS: Standard rehabilitation after admission in the first phase. RAGT for two weeks in the second phase. OUTCOME MEASURES: Self-selected walking speed (SWS), step length, cadence, and the 6-minute walking distance were the primary outcomes. Walking Index for SCI score, lower extremity motor score, and spasticity were measured. Walking abilities were compared between the two periods using a generalized linear mixed model (GLMM). Correlations between assessments and changes in walking abilities during each period were analyzed. RESULTS: After standard rehabilitation for 66.1 ± 36.9 days, a period of 17.6 ± 3.3 days of RAGT was safely performed. SWS increased during both periods. GLMM showed that the increase in cadence was influenced by standard rehabilitation, whereas the limited step length increase was influenced by RAGT. During RAGT, the increase in step length was related to an increase in hip flexor function. CONCLUSIONS: Gait speed in patients with SCI increased after rehabilitation, including RAGT, in the short-term. This increase was associated with improved muscle function in hip flexion at the start of RAGT.Trial Registration: This study was registered with the UMIN Clinical Trials Registry (UMIN-CTR; UMIN000042025).

Muscle Strength and Efficiency of Muscle Activities Recovery Using Single-Joint Type Hybrid Assistive Limb in Knee Rehabilitation after Anterior Cruciate Ligament Reconstruction.

Decreased muscle strength often occurs after anterior cruciate ligament (ACL) reconstruction; this can include muscle atrophy, neuromuscular dysfunction, and reduced force generation efficiency. Hybrid assistive limb (HAL) technology, which integrates an interactive biofeedback system connecting the musculoskeletal system to the brain and spinal motor nerves, offers a potential intervention. Our study, conducted from March 2018 to August 2023 using knee HAL single-joint technology, was a prospective non-randomized controlled trial involving 27 patients who had undergone arthroscopic ACL reconstruction. They were split into two groups: HAL (18 patients) and control (nine patients). Beginning 18 weeks after their surgery, the HAL group participated in three weekly sessions of knee HAL-assisted exercises. Both the HAL and control groups underwent isokinetic muscle strength tests at postoperative weeks 17 and 21. Testing utilized an isokinetic dynamometer at 60°/s, 180°/s, and 300°/s. The Limb Symmetry Index (LSI) was employed to measure side-to-side differences. The HAL group showed significant LSI improvements in peak extension torque across all testing velocities and for peak flexion torque at 60°/s and 300°/s. The rate of change in LSI for peak flexion torque at 300°/s was significantly higher post-measurements (p = 0.036; effect size = 1.089). The change rate for LSI in peak extension torque at 300°/s and all peak flexion torques showed medium to large effect sizes in Cohen's d. In conclusion, knee HAL single-joint training positively influenced muscle strength recovery and efficiency. The HAL training group exhibited superior muscle strength at various isokinetic testing velocities compared to the control group.

Evaluation of hand functions and distal radioulnar joint instability in elite wheelchair basketball athletes: a cross-sectional pilot study.

BACKGROUND: Wrist injury affects wheelchair basketball players' performance; however, the relationship between distal radioulnar joint (DRUJ) instability and hand functions is unclear. This cross-sectional pilot study investigated DRUJ instability in elite female wheelchair basketball athletes using force-monitor ultrasonography. METHODS: Nine elite female wheelchair basketball athletes (18 wrists) were included in the study. A triangular fibrocartilage complex (TFCC) injury was confirmed using magnetic resonance imaging (MRI). Hand functions were evaluated based on the range of motion (ROM) of wrist palmar flexion, dorsiflexion, radial deviation, and ulnar deviation; grip strength; arm circumference; forearm circumference; and DRUJ instability or pain using the ballottement test. The Mann-Whitney U test was used to compare parameters between the TFCC-injured and intact wrists. Radioulnar displacement was measured using force-monitor ultrasonography and pressure data, and the displacement-to-force ratio was used as an indicator of DRUJ instability. The correlation between the DRUJ displacement-to-force ratio and each hand function assessment was evaluated using Pearson correlation coefficient for the TFCC-injured and intact wrists. A generalized linear mixed model (GLMM) was used to estimate the relationship between hand functions and DRUJ instability. RESULTS: TFCC injuries in seven wrists were confirmed using MRI findings (38.9%). The ulnar deviation ROM values of the TFCC-injured wrist (n = 7) and intact (n = 11) groups were 38.6 ± 8.0° and 48.6 ± 7.8°, respectively. The ulnar deviation ROM was significantly smaller in the TFCC-injured wrists (p = 0.02, r = - 0.54). In the TFCC-injured wrists, no correlation was observed between the displacement-to-force ratio and the hand function assessment. In contrast, the displacement-to-force ratio negatively correlated with grip strength, arm circumference, and forearm circumference in the intact wrists (Pearson correlation coefficient r = - 0.78, - 0.61, and - 0.74, respectively). The GLMM showed that the displacement-to-force ratio significantly affected grip strength, arm circumference, and forearm circumference in the intact group. CONCLUSIONS: In intact wrists, correlations were observed between hand functions such as upper arm/forearm strength and DRUJ stability evaluated using ultrasound. Maintaining and strengthening grip strength, forearm circumference, and arm circumference are associated with DRUJ stability and may be related to TFCC injury prevention in wheelchair basketball athletes. TRIAL REGISTRATION: The protocol was registered with the UMIN Clinical Trials Registry (UMIN000043343) [Date of first registration: 16/02/2021].

Reasons for the Reporting Behavior of Japanese Collegiate Rugby Union Players Regarding Suspected Concussion Symptoms: A Propensity Analysis.

While previous research has identified the reasons for the concussion-reporting behavior of rugby union players, the influence of confounding factors such as concussion experience, education, and knowledge of concussion symptoms, any of which may have influenced the results, has not been considered. This study aimed to clarify the reasons for the reporting behavior of college rugby union players regarding suspected concussion symptoms by adjusting for confounding factors using the propensity score. A questionnaire about both concussion knowledge and concussion-reporting behavior was administered to 240 collegiate rugby union players. Of the 208 (86.7%) valid respondents to the questionnaire, 196 (94.2%) had experienced any one symptom of a suspected concussion, such as headache, at least once, and 137 (65.9%) reported symptoms to someone else. This study's results revealed two important reasons for reporting symptoms: (1) the willingness of players to report experienced symptoms to someone else, along with realizing a concussion, and (2) the willingness of players to report suspected concussion symptoms, despite the absence of a doctor or trainer. These results suggest that providing educational opportunities to recognize suspected concussion symptoms and establishing a team culture of reporting physical problems to someone else is important for improving concussion-reporting behavior.

Application of force-monitor ultrasonography to assess distal radioulnar joint instability in patients with triangular fibrocartilage complex injury.

Introduction: In this study, we evaluated the differences and measurement accuracy in the force-displacement relationship of the distal radioulnar joint (DRUJ) between patients with triangular fibrocartilage complex (TFCC) injury and healthy controls using force-monitor ultrasonography. Methods: This study included 11 TFCC injury patients and 22 healthy controls. We evaluated differences in the force-displacement relationship of the DRUJ in these patients using force-monitor ultrasonography. Cyclic compression was applied to the dorsal surface of the ulnar head. Distance between the dorsal surface of the distal radius and ulnar head at the DRUJ level was measured in the initial and pressed-down positions. Changes in radioulnar displacement, applied force, and displacement-to-force ratio were measured. Furthermore, we compared the parameters between the affected and unaffected wrists and between TFCC injury patients and controls. Results: The radioulnar displacement and displacement-to-force ratio were significantly larger in the affected wrists than in the unaffected wrists (P = 0.003 and P = 0.02). The affected/unaffected side ratio of radioulnar displacement and displacement-to-force ratio were significantly larger in the TFCC injury patients than in the controls (P = 0.003 and P = 0.02). The area under the curve was 0.82 for the affected/unaffected ratio of the radioulnar displacement. The optimal cutoff value indicated by the receiver-operating characteristic curve for the affected/unaffected ratio of the radioulnar displacement was 1.71; the sensitivity and specificity were 82% and 86%, respectively. Conclusions: Assessing the DRUJ instability with force-monitor ultrasonography may help identify TFCC-injured wrists.

Influence of the Amount of Change in Quadriceps Tendon Young's Modulus on Amount of Change in Walking Speed before and after Total Knee Arthroplasty.

Background and Objectives: Walking speed after total knee arthroplasty (TKA) is an important outcome. However, the effect of quadriceps tendon stiffness on walking speed remains unclear. This study aimed to clarify the influence of the amount of change in quadriceps tendon stiffness on the degree of change in walking speed before and after TKA. Materials and Methods: Sixteen patients who underwent TKA for knee osteoarthritis participated in this study (median age: 74.0 years (interquartile range: 64.5-75.8)). Shear-wave elastography was deployed to measure quadriceps tendon stiffness using Young's modulus. A motion analysis system was used to assess kinematic parameters and walking speed. Participants' knee circumference, range of motion, extension strength, one-leg standing time, walking pain level, and activity level were measured preoperatively and one year after TKA, and changes in values were calculated. We used path analysis to clarify the influence of the amount of change in the quadriceps tendon Young's modulus on the change in walking speed. Results: The quadriceps tendon Young's modulus negatively affected the knee flexion angle during swing (standardized partial regression coefficients (ß) = -0.513, p = 0.042). The knee flexion angle during swing positively affected step length (ß = 0.586, p = 0.017). Step length positively affected cadence (ß = 0.733, p = 0.001). Step length and cadence positively affected walking speed (ß = 0.563, p < 0.001, ß = 0.502, p < 0.001, respectively). Conclusions: The amount of change in the quadriceps tendon Young's modulus may affect the degree of change in walking speed after TKA through the amount of change in the knee flexion angle during swing, step length, and cadence. Clinically, reducing quadriceps tendon stiffness can be addressed in rehabilitation programs to increase walking speed after TKA.

Effect of Training With the Hybrid Assistive Limb on Gait Cycle Kinematics After Total Knee Arthroplasty.

INTRODUCTION: Reportedly, wearable robots, such as the hybrid assistive limb (HAL), are effective in the functional recovery of various locomotor disabilities, including disrupted walking, restricted range of motion, and muscle weakness. However, the effect of walking exercises with a HAL on the kinematic and kinetic variables of lower limb joint function is not yet fully understood. Therefore, the purpose of this study was to elucidate the effect of HAL on the kinematic and kinetic variables of lower limb function in patients 5 weeks after total knee arthroplasty (TKA). MATERIALS AND METHODS: Nine patients (ten knees) in the HAL training group and nine patients (nine knees) in the control group underwent TKA. HAL training was initiated 1-5 weeks after TKA, and general rehabilitation was performed in the control group. Gait analysis was performed on each patient using a motion analysis system at 5 weeks after TKA. We compared the effects of the joint angles of the walking cycle between groups, and investigated the effect of the walking cycle's joint angles on step length. RESULTS: In the HAL group, the odds ratio of hip extension was as large as 1.741, while that of knee swing was as large as 1.501. These 2 variables were significant between the 2 groups. Knee swing and varus significantly affected step length. CONCLUSIONS: Our results suggest that training by wearing HAL after TKA increased the mobility of the knee and hip joints during early postoperative walking, and that walking ability was improved by increasing the step length.

Difference in Personality Traits and Symptom Intensity According to the Trigger-Based Classification of Throwing Yips in Baseball Players.

The triggers of initial onset of yips symptoms can be broadly divided into psychological and non-psychological factors; however, a trigger-based classification of yips has not been established. This study aims to obtain insight into the prevention of yips by clarifying whether there are differences in symptoms and personality traits according to a trigger-based classification of yips in baseball players. A total of 107 college baseball players responded to a questionnaire assessing the presence or absence of yips and its symptoms. They were classified into the psychologically triggered yips group, the non-psychologically triggered yips group, and the non-yips group based on the presence or absence of yips and the triggers of its initial onset. Additionally, we compared whether personality traits examined by the NEO Five-Factor Inventory differed across these three groups. The psychologically triggered yips group had significantly higher agreeableness scores compared with the non-yips group, whereas the non-psychologically triggered yips group had significantly higher neuroticism scores compared with the psychologically triggered yips group. In the non-psychologically triggered yips group, there was a significantly higher frequency of throwing errors than in the psychologically triggered yips group, with a tendency to develop yips symptoms gradually. Since the trigger-based classification of yips is closely related to the strength of the yips symptoms and the players' personality traits, the results of this study contribute to a better understanding of the symptoms of yips and establishment of the prevention of yips. Large prospective studies are necessary to determine the causal relationship between a trigger-based classification of yips and the personality traits and symptoms of athletes with yips.

Interpretation of causal relationship between quadriceps tendon Young's modulus and gait speed by structural equation modeling in patients with severe knee osteoarthritis.

PURPOSE: To clarify the causal relationship between quadriceps tendon stiffness and gait speed in patients with severe knee osteoarthritis (OA) using structural equation modeling. METHODS: Participants were 36 patients with knee OA (median age, 75.0 [interquartile range, 67.3-76.0] years; Kellgren-Lawrence grade 3 or 4). We measured quadriceps tendon stiffness using Young's modulus by ShearWave Elastography. Gait speed and kinematics parameters were measured using a motion analysis system. Additional data collected for each patient included age, sex, height, body weight, body mass index, femorotibial angle, knee range of motion, knee extension torque, and pain. We performed structural equation modeling for interpretation of the causal relationship. RESULTS: The comparative fit index of the structural equation modeling was 0.990. Quadriceps tendon Young's modulus was a predictor of maximum knee flexion angle during the swing phase (standardized partial regression coefficients [ß] = -0.67, P < 0.001). Maximum knee flexion angle during the swing phase was a predictor of cadence and step length (ß values 0.35 and 0.55, P = 0.035 and <0.001, respectively). Cadence and step length were predictors of gait speed (ß values 0.50 and 0.63, P < 0.001 and <0.001, respectively). CONCLUSION: Our results showed a causal relationship between quadriceps tendon stiffness and gait speed in patients with severe knee OA. Quadriceps tendon Young's modulus can affect gait speed through the maximum knee flexion angle during the swing phase, cadence, and step length. Adding therapeutic intervention to decrease the quadriceps tendon Young's modulus may lead to increased gait speed.

Early Recovery of Walking Ability in Patients After Total Knee Arthroplasty Using a Hip-Wearable Exoskeleton Robot: A Case-Controlled Clinical Trial.

INTRODUCTION: The Honda Walking Assist (HWA) is a hip-wearable exoskeleton robot for gait training that assists in hip flexion and extension movements to guide hip joint movements during gait. This study aimed to evaluate the effects of walking exercises with HWA in patients who underwent total knee arthroplasty (TKA). MATERIALS AND METHODS: This study involved 10 patients (11 knees) in the HWA group and 11 patients (11 knees) in the control group who underwent conventional physical therapy. The patients assigned to the HWA group underwent a total of 17-20 gait training sessions, each lasting approximately 20 min from week 1 to 5 following TKA. Self-selected walking speed (SWS), maximum walking speed (MWS), range of motion (ROM), knee extension and flexion torque, and Western Ontario and McMaster Universities Osteoarthritis Index subscales of pain (WOMAC-p) and physical function (WOMAC-f) scores were measured preoperatively, at 2, 4, and 8 weeks following TKA. RESULTS: Interventions were successfully completed in all patients, with no severe adverse events. A significant difference was noted in the time × group interaction effect between preoperative and week 2 SWS and MWS. Regarding knee function, there was a significant difference in the time × group interaction between preoperative and week 2 active ROM extension; however, no significant difference in knee torque, WOMAC-p, and WOMAC-f scores were observed. In the between-group post hoc analysis, WOMAC-f in the HWA group was higher than that in the control group at week 8. DISCUSSION: Although the control group showed a temporary reduction in SWS and MWS 2 weeks after TKA, the HWA group did not. These results suggest that HWA intervention promotes early improvement in walking ability after TKA. CONCLUSIONS: The gait training using HWA was safe and feasible and could be effective for the early improvement of walking ability in TKA patients.

How does the situation before a tackle influence a tackler's head placement in rugby union?: application of the decision tree analysis.

OBJECTIVES: Tacklers need to decide where to place their head based on the evasive manoeuvres of the ball-carrier and positional relationship with the ball-carrier before tackle. Therefore, it is difficult for tacklers to improve incorrect head placement at the moment of contact. Moreover, the characteristics prior to tackle have a relationship with the tackler's head placement. However, how situations lead to incorrect head placement remains unknown. The aim of this study was to identify pre-contact situations that lead to incorrect head placement by using decision tree analysis. METHODS: Tackles leading to concussions were used to identify events that provoked injury using the video recordings of matches. Injury-free tackle was used as a control. All tackles were classified according to head placements and coded from seven pre-contact factors configured aspect of both tacklers and ball-carriers. RESULTS: Three situations that led to incorrect head placement were identified. Evasive manoeuvres implemented by the ball-carrier significantly contributed to the head placement at the time of contact. CONCLUSION: Our findings suggest that tacklers should keep their heads up to identify the movements of the ball-carrier, which might lead to tackling the head on the correct side at the moment of tackling and decrease the risk of tackler-related concussions.

Assessment of distal radioulnar joint stability in healthy subjects: Changes with dominant hand, sex, and age.

This study aimed to elucidate the differences in distal radioulnar stability in dominant/nondominant hand, sex, and age. Bilateral wrists of 60 healthy subjects were evaluated using force-monitoring ultrasonography. This apparatus was developed to apply cyclic compression and measure applied force to displacement during an ultrasound exam. The transducer was placed on the dorsal side of the distal radioulnar joint, and the center of the ulnar head was displayed on the monitor. The distance between the dorsal surface of the distal radius and the ulnar head was measured at an initial and at a pressed-down position. The radioulnar displacement, applied force to displacement, and displacement-to-force ratio were evaluated. The results were compared between the dominant and nondominant hands, and between males and females, and among different age groups. There were no significant differences in the parameters between the dominant and nondominant hands. The applied force to displacement was significantly greater in the male group compared with the female group. There were significant effects for the different age groups in all parameters (displacement: F = 3.67, p = .008; applied-force: F = 3.08, p = .019; displacement-to-force ratio: F = 4.66, p = .002). Our results indicated that the stability of distal radioulnar joint differed depending on age and sex. Age and sex should be considered when assessing distal radioulnar joint stability.

Characteristics and factors of concussion events for tacklers in collegiate rugby union.

The purpose of this study was to determine the factors related to the occurrence of concussion in rugby tacklers. Match video records showing tackles leading to concussion were used to identify injury-inciting events. Additionally, noninjury tackles by concussed tacklers (prior to concussion) and position-matched tacklers from the same matches were used as a control cohort. All tackles were coded according to the tackling characteristics. The odds ratio (OR) was reported by logistic regression. The results demonstrated that a side step of the ball-carrier reduced the risk of concussion for tacklers (OR = 0.13 [95% CI, 0.03-0.58]; P = .008). Conversely, the tackler's head/neck contacting the ball-carrier (OR = 18.62 [95% CI, 4.59-75.49]; P < .001) and not remaining bound to the ball-carrier since making initial contact (OR = 4.38 [95% CI, 1.69-11.34]; P = .002) were identified as risk factors for the concussion of tacklers. These results suggest that avoidance movements of the ball-carrier prior to tackling reduced the risk of concussion and that incorrect tackling techniques contributed to an increased occurrence of concussion. Furthermore, the probability of concussion for tacklers increased when their head was in front or to one side of the ball-carrier, and the direction of the tackle also affected the risk of concussion, especially from the side. Therefore, it is important to emphasize the tackler's head position in conjunction with the direction of tackle.

A Short-Duration Combined Exercise and Education Program to Improve Physical Function and Social Engagement in Community-Dwelling Elderly Adults.

Exercise is a key intervention for improving older adults' physical function and life expectancy. Here, we investigated a short-term intervention program designed to improve the physical functioning of elderly adults in a community-dwelling setting. We examined the effect of a 5-week combined exercise and education program on the physical function, social engagement, mobility performance, and fear of falling in 42 subjects older than 65 years. Eleven subjects dropped out. There was significant improvement in the 30-second chair stand test (p < .001) and timed up-and-go test (p < .001) between the baseline and the last session. At the end of the intervention, the subjects' social engagement was significantly higher than at baseline (p = .022), but this improvement was not maintained in the follow-up assessment. These results suggest that a combined exercise and education program can improve the physical function and social engagement of elderly individuals living in a community dwelling.

Failure risks in anatomic single-bundle anterior cruciate ligament reconstruction via the outside-in tunnel technique using a hamstring autograft.

PURPOSE: To retrospectively evaluate the failure risk factors in anatomic single-bundle anterior cruciate ligament (ACL) reconstruction via outside-in tunnel technique using a hamstring autograft, and investigate the relationship between each risk factor. METHODS: The patients who underwent the ACL reconstruction with a minimum 1-year follow-up were included. We divided the patients into two groups - those who experienced graft failure (the failure group) and those who did not experience graft failure (the no failure group) - and compared their age, height, weight, sports activity level, graft size, and muscle strength. We defined graft failure as patients who underwent revision ACL reconstruction or had a second injurious ACL episode and those with a graft grade of C or D based on the International Knee Documentation Committee score. RESULTS: The study included 232 patients (101 male, 131 female; mean age at operation was 26.1 ±â€¯11.9 years). The failure rate was 11.6% (failure group: 27 patients; no failure group: 205 patients). The patients in the failure group were younger and had higher sports activity level than those in the no failure group. (p < 0.001 and p < 0.001, respectively). Patient body weight in the failure group was lower than that in the no failure group (p = 0.047). Regarding the graft size of the tibial side, the failure group had smaller graft sizes than the no failure group (p = 0.030). With respect to muscle strength, quadriceps strength 6 months after surgery in the failure group was stronger than that in the no failure group (p = 0.001). In addition, the hamstring/quadriceps strength (H/Q) ratios 3 and 6 months after surgery were lower in the failure group than that in the no failure group (p = 0.041 and p = 0.001, respectively). There was an association between the age and the body weight, between the body weight and the graft size of the tibial side, and between lower age and high sports activity. Moreover, the high quadriceps strength at 6 months and the low H/Q ratio at 3 months were related to the low H/Q ratio at 6 months. CONCLUSION: Young age, high activity sports level, low body weight, small graft diameter of the tibial side, high quadriceps strength at 6 months, and low H/Q ratio at 3 and 6 months can be failure risk factors in anatomic single-bundle ACL reconstruction via the outside-in tunnel technique using a hamstring autograft.

Contributions to the team score by male wheelchair basketball players with different physical capacities at the Rio 2016 Paralympics.

[Purpose] The contributions of male wheelchair basketball players with different capability classifications to the team score at the Rio 2016 Paralympics were evaluated. The roles required for team members belonging to each such classification were determined. [Participants and Methods] Statistics obtained from the official box scores of all 42 games included at the Rio 2016 Paralympics were used in this study. Players who participated for >20 minutes in each game were included in the analysis. Players were divided into 3 groups (low, middle, and high) based on their capability classification. The mean statistical data related to each group were compared, and the covariance structure was analyzed to determine the role of each player group. [Results] Many statistical values were higher in players belonging to the high group. In the high group, the relevant variables were field goals scored, field goals attempted, assists, and turnovers. In the low group, the relevant variables were field goals scored, steals, and turnovers. [Conclusion] Many plays related to the ball depended on the high group. High-group players are required to demonstrate strong scoring ability and to reduce turnovers. Conversely, low-group players should increase the numbers of field goals made, increase steals, and reduce turnovers.

Difference in contributions to the team's score in female wheelchair basketball at the 2016 Rio Paralympics by physical capability classification.

[Purpose] This study clarified differences in players' contributions to the team's score in female wheelchair basketball at the 2016 Rio Paralympics by physical capacity classification, and examined the roles required in the team. [Subjects and Methods] This study used stats (record of play contents) for players who played for more than 20 minutes from the official box scores of all 31 games at the 2016 Paralympics. Players were divided into three groups by physical capacity classification: low, middle, and high. The average stats for each group were compared and the covariance structure was analyzed to determine the role of each group during the game. [Results] Comparisons showed that the higher the class, the higher the value of many stats items. Important elements were defensive rebound, steal, and turnover in the low group; and score, offensive rebound, and turnover in the high group. [Conclusion] Players in the high group have more plays related to the ball. Those in the low group should increase the numbers of steals and defensive rebounds and reduce turnover. High group players are required to have scoring ability, acquire offensive rebound, and reduce turnover.

Efficacy and safety of certolizumab pegol without methotrexate co-administration in Japanese patients with active rheumatoid arthritis: the HIKARI randomized, placebo-controlled trial.

OBJECTIVE: This 24-week, placebo-controlled, double-blind, randomized study (NCT00791921) investigated efficacy and safety of certolizumab pegol (CZP) in Japanese rheumatoid arthritis (RA) patients in whom methotrexate (MTX) cannot be administered. METHODS: A total of 230 patients were randomized to subcutaneous CZP 200 mg (induction dosing: 400 mg at Weeks 0, 2 and 4) or placebo every 2 weeks. RESULTS: ACR20 responses with CZP were rapid and significant versus placebo at Week 1, sustained to Week 12 (67.2% vs. 14.9%) and Week 24 (63.8% vs. 11.4%). Week 24-modified Total Sharp Score (mTSS) change from baseline (CFB) was 0.48 (CZP) versus 2.45 (placebo). CZP treatment was associated with higher Week 12 ACR20 responses versus placebo (with non-MTX disease modifying antirheumatic drugs [DMARDs], 74.2% vs. 20.0%; without [monotherapy], 59.3% vs. 8.2%) and inhibition of radiographic progression at Week 24 (mTSS CFB; with non-MTX DMARDs, 0.24 vs. 1.61; monotherapy, 0.68 vs. 3.65). Incidences of serious adverse events were 11.2% (CZP) and 2.6% (placebo); one CZP patient died of dissecting aortic aneurysm. CONCLUSION: CZP treatment with and without non-MTX DMARDs in Japanese patients in whom MTX cannot be administered resulted in rapid, sustained reductions in RA signs and symptoms. Notably, CZP monotherapy showed significant inhibition of radiographic progression.

Effect of tea catechins on mitochondrial DNA 4977-bp deletions in human leucocytes.

The catechins in green tea have antioxidative and antimutagenic effects. We examined the effect of green tea enriched with catechins on the presence of mitochondrial DNA (mtDNA) with a common 4977-bp deletion mutation (mtDNA4977) in human leucocytes. Ten healthy females [aged 20.80 +/- 1.03 years] drank 350 ml of catechin-rich tea daily after supper for 5 weeks. Blood samples were collected twice before, and twice after 5 weeks of consuming the tea. Deletions in mtDNA were analyzed using the nested polymerase chain reaction (PCR). We identified a common mtDNA4977 deletion in nine participants before drinking the tea. However, this mtDNA4977 deletion was not evident in leucocytes from most of the participants 5 weeks after drinking the tea. Catechins found in tea might contribute to the maintenance of health status by reducing damage to mtDNA and by maintaining the capacity of mtDNA for oxidative phosphorylation.

Serial changes in independent sitting in adults with severe cerebral palsy.

We investigated the natural course of independent sitting in 28 institutionalized patients with severe cerebral palsy (CP) and evaluated the factors associated with presence or absence of independent sitting during adulthood. Seventeen subjects (61%) who could not sit at the age of 10 years were never able to reach the milestone of independent sitting. Five (45%) of 11 subjects subsequently lost the ability to sit independently during the early stage of adult life. In adulthood, many of the dependent sitters had poor activities of daily living (ADL) scores and required medical care for respiration and eating/swallowing. Hip dislocation was not directly associated with the presence or absence of independent sitting. We conclude that it is important to prevent further deterioration of swallowing and respiratory functions, as well as the development of deformities or contractures from childhood and to maintain previously acquired motor function and ADL in adults with severe CP.